NCT02855359

Denintuzumab Mafodotin (SGN-CD19A) Combined With RCHOP or RCHP Versus RCHOP Alone in Diffuse Large B-Cell Lymphoma or Follicular Lymphoma

An Open Label Phase 2 Study of Denintuzumab Mafodotin (SGN-CD19A) in Combination With RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) or RCHP (Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone) Compared With RCHOP Alone as Frontline Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL) or Follicular Lymphoma (FL) Grade 3b

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 study to evaluate the combination of denintuzumab mafodotin in combination with RCHOP or RCHP compared with RCHOP alone as front-line therapy in patients with diffuse large B-cell lymphoma or follicular lymphoma Grade 3b.

Detailed description

In Part A of the study, patients will be randomized 1:1 to receive denintuzumab mafodotin plus RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) or denintuzumab mafodotin plus RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) to assess the safety of these 2 combination regimens. Part B of the study is designed to evaluate the antitumor activity and safety of denintuzumab mafodotin in combination with either RCHOP or RCHP (Experimental Arm) compared with RCHOP alone (Comparator Arm).

Conditions

• Diffuse, Large B-Cell, Lymphoma
• Follicular Lymphoma, Grade 3b
• Transformed Lymphoma / DLBCL

Interventions

Type	Name	Description
DRUG	denintuzumab mafodotin	SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles
DRUG	rituximab	375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
DRUG	cyclophosphamide	750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
DRUG	doxorubicin	50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
DRUG	vincristine	1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
DRUG	prednisone	100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles

Timeline

• Start date: 2016-08-01
• Primary completion: 2018-01-01
• Completion: 2018-05-15
• First posted: 2016-08-04
• Last updated: 2019-03-11
• Results posted: 2019-01-08

Locations

35 sites across 2 countries: United States, Puerto Rico